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Chlorpyrifos Chemical Review

In progress

This work plan has been prepared to fulfill new legislative requirements intended to improve the transparency and predictability of chemical review decisions. Work plans for all current chemical reviews have been prepared in accordance with subsection 31(2) of the Agvet Code and set out the remaining work to be completed and the maximum legislative timeframe by which a decision must be made. The timeframes have been calculated according to the formula specified in Section 78B of the Agricultural and Veterinary Chemicals Code Regulations 1995. The APVMA will update these work plans at least yearly or as necessary.

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Work plan

Work plan

Click on one of these tabs for more information about that phase in the review process. For more information about how each phase is conducted, please read the reconsideration process.

Chemicals

Chlorpyrifos

Nomination Reason

Environment

Human health

Occupational health and safety

1. Nomination

1. Nomination

Phase status:

Completed

In December 1996, the APVMA (then the NRA) began a review of chlorpyrifos as part of the Existing Chemicals Review Program. Chlorpyrifos was nominated for review because of concerns about its human toxicity, its acute toxicity to birds and its water pollution potential; United States restrictions imposed to reduce hazards to fish, birds and other wildlife; a demonstrated potential for adverse effects in users; and high-potential chronic and moderate-potential acute toxicity risk.

2. Prioritisation

2. Prioritisation

Phase status:

Completed

3. Scoping and work plan

3. Scoping and work plan

Phase status:

Completed

4. Notice of reconsideration

4. Notice of reconsideration

Phase status:

Forecasted

5. Assessment

5. Assessment

Phase status:

In Progress

In January 2000, the APVMA (then known as NRA) released a Chlorpyrifos interim review report which summarised the outcomes of interim chemistry, agricultural, toxicological, occupational health and safety and environmental assessment reports. The report found that some home and garden formulations of chlorpyrifos could pose an unacceptable health and safety risk and that there were potential environmental concerns, particularly for birds and fish. As a result, several regulatory measures were implemented including label amendments with updated directions for use, first aid and safety directions, and environmental warning statements.

The interim review report also found that there were inadequate data to support several uses of chlorpyrifos. Additional residues data subsequently submitted to the APVMA formed the basis of a preliminary review findings report on additional residues data (2009) recommending further label amendments and the establishment of permanent maximum residue limits (MRLs) in the MRL Standard.

The supplementary toxicology assessment found no evidence to indicate potential neurodevelopment effects to occur at or below doses of chlorpyrifos that are used to establish the acceptable daily intake (ADI) and acute reference dose (ARfD). The current ADI of 0.003 mg/kg bw/d, ARfD of 0.1 mg/kg bw and the poison schedule (Schedule 6) for chlorpyrifos remain appropriate.

Revised timeline

Chemical Reviews (reconsiderations) are dynamic and our work plans must be flexible to consider:

new scientific information

our response to emerging issues that may need regulatory action to address.

The Chlorpyrifos work plan has been reviewed and updated in line with the legislation and associated regulations. We have received additional assessment data from approval and registration holders since the review started on 1 July 2015, so the modular assessment levels in this work plan have been adjusted.

The Chlorpyrifos review scope and work plan has been adjusted to include a residues level 5.2 assessment (previously a level 5.4) and environment level 7.1 assessment (previously a level 7.2). The recalculated timeframe for the Chlorpyrifos Review is 37 months. We expect the review findings and proposed recommendations to be available for public comment in August 2018.

6. Draft regulatory measure

Phase status:

Forecasted

In September 2000, the APVMA released the Chlorpyrifos interim review report. In the report, the APVMA proposed restricting home and garden products to concentrations of not greater than 50 grams per litre. The APVMA also found that there were inadequate residues data for the use of chlorpyrifos in some commodities. The APVMA proposed varying product labels to strengthen environmental protection warnings, safety directions and re-entry period statements. These regulatory actions were implemented in 2001–02.

In September 2009, the Preliminary review findings report, which considered supplementary residues data and provided a summary update on the toxicity of chlorpyrifos, was released for public comment.

As a result of this review, the APVMA:

restricted liquid formulations sold for domestic use to a concentration of no greater than 50 grams per litre

removed approval for the use of chlorpyrifos in indoor broadcast applications involving spraying surface areas, such as floors and walls

strengthened label instructions concerning the times and conditions governing worker re-entry to and reoccupation of treated areas

amended product labels to include clear warnings on use practices that would avoid the potential for environmental harm.

The review findings and decisions were considered to be interim until further data were collected on residue levels in commodities to provide the basis for the re-establishment of permanent maximum residue levels (MRLs) for individual crops. These data have been generated and assessed.

The APVMA will finalise the report when the assessment of all available data has been completed and public comments have been received and considered.